Respiratory apparatus having an introduction section configured for releasable attachment with a respiratory instrument

ABSTRACT

A respiratory apparatus includes an instrument introduction section that is adapted for introducing an instrument into an artificial airway of a patient. The instrument introduction section has a distal end and a proximal end with an opening that allows for insertion of the instrument into the instrument introduction section. The instrument is movable through a passageway between the distal and proximal ends. The distal end is configured for releasable attachment with an artificial airway structure that is attached to the patient. Further, a valve is located in the instrument introduction section. The valve has a closed position in which the passageway is at least substantially isolated from the artificial airway of the patient when the instrument is present and is proximal from the valve. The valve at least substantially blocks the passageway of the instrument introduction section when the valve is in the closed position. The valve also has an open position that allows for the instrument to be moved through the instrument introduction section and into the artificial airway of the patient.

BACKGROUND

[0001] A variety of different circumstances exist in which a person maybe required to have an artificial airway, such as an endotracheal tube,placed in his or her respiratory system. During surgery, for instance,the artificial airway's primary function is to keep the patient's airwayopen so that adequate lung ventilation can be maintained during thesurgical procedure. Alternatively, with many patients the endotrachealtube will remain in place to sustain mechanical ventilation for aprolonged period.

[0002] If an endotracheal tube is to be left in place for anysubstantial amount of time, it is critical that respiratory secretionsbe periodically removed. This is usually accomplished with the use of arespiratory suction catheter. As the suction catheter is withdrawn, anegative pressure may be applied to the interior of the catheter to drawmucus and other secretions from the respiratory system.

[0003] With conventional closed suction catheter assemblies, for exampleas the one set forth in U.S. Pat. No. 4,569,344 issued to Palmer, whichis incorporated by reference herein in its entirety for all purposes,the catheter tube is enveloped by a protective sleeve. The catheterassembly includes a valve mechanism in communication with a vacuumsource to control the suctioning process. At its distal or patient end,the closed suction catheter assembly is permanently attached to amanifold, connector, adaptor, or the like.

[0004] After the application of negative pressure, the catheter tube maybe withdrawn from the artificial airway and, as the catheter tube ispulled back into the protective sleeve, a wiper or seal strips orscrapes a substantial portion of any mucus or secretions from theoutside of the catheter tube. However, the distal tip portion of thecatheter tube may not pass through the seal or wiper and thus anysecretions or mucus on the distal end must be removed by other means. Itis desirable to remove these secretions from the catheter tube in orderto prevent contamination from infectious agents that may be present inthe respiratory secretions. Patients using artificial airways often havecompromised immune systems and are more susceptible to infectiousagents.

[0005] Several mechanisms exist by which a catheter may be cleaned. Forexample, a lavage port may be included which enables the clinician toinject liquid into the area surrounding the tip of the catheter after ithas been withdrawn from the patient's airway. When liquid is injectedand suction is applied, the liquid helps to loosen and remove thesecretions from the exterior of the catheter.

[0006] One significant problem with simply injecting liquid and applyingsuction is that the suction also causes a volume of respiratory air tobe removed through the catheter. The air that is evacuated potentiallydisrupts the carefully controlled ventilation cycle and therefore theamount of respiratory air available to the patient may be decreased as aresult of catheter cleaning.

[0007] Prior respiratory suction catheter apparatuses have beendeveloped in order to allow for cleaning of the distal tip of thecatheter without substantially interrupting the airflow to the patientfrom the ventilator. U.S. Pat. No. 6,227,200 B1 issued to Crump et al.,which is incorporated by reference herein in its entirety for allpurposes, provides in one exemplary embodiment a flap valve that may beused to substantially isolate the distal end of the catheter from thepatient's airway during cleaning. The flap valve also has an openposition in which the catheter may be inserted through the manifold intothe airway of the patient. Current respiratory suction catheterapparatuses incorporate the flap valve and related structure such thatthese parts are permanently bonded to the manifold.

[0008] Although respiratory suction catheter apparatuses are providedwith a cleaning mechanism in order to remove mucus and other infectiousagents, it is often the case that the catheter itself needs to beregularly replaced in order to insure a more sterile respiratorycircuit. Some respiratory suction catheter manufacturers recommendreplacement of the suction catheter every 24 hours with a new suctioncatheter. In the instance when the suction catheter needs to bereplaced, the manifold into which the flap valve and related parts arecontained, and onto which the suction catheter is attached, is detachedfrom the respiratory circuit. This detachment necessarily interfereswith the supply of air to the patient, and increases the chances ofventilator associated complications. The new manifold with attachedcatheter and valve is then connected to the ventilator circuit.

[0009] Also, it is often the case that the suction catheter ispermanently attached to the structure that houses the valve and relatedcleaning elements. As such, other instruments which may be desired to beadvanced into the artificial airway, such as an endoscope or abronchoscope, can not be advanced through the manifold. Additionally,these other instruments are not capable of being cleaned by the use ofthe valve and/or cleaning structure due to the presence of the suctioncatheter and its attachment to the manifold.

[0010] Therefore, there is a need in the art for a respiratory apparatusthat is capable of effectively cleaning the tip of an instrument withouta resulting drop of ventilation air to the patient. Additionally, a needin the art exists in replacing a respiratory apparatus with a newrespiratory apparatus without disconnecting the manifold from theventilation circuit in order to prevent air loss to the patient, and tolower the chances of imparting illness to the patient during thereplacement procedure.

SUMMARY

[0011] Various features and advantages of the invention will be setforth in part in the following description, or may be apparent from thedescription, or may be learned from practice of the invention.

[0012] The present invention provides for a respiratory apparatus thatmay be removed from a ventilation circuit of a patient and replacedwithout having to disconnect an artificial airway structure from theventilation circuit. An instrument introduction section is present andmay be adapted for introducing an instrument into the artificial airwayof the patient. The instrument introduction section is provided with aproximal end that may have an opening that allows for insertion of theinstrument. The instrument introduction section may have a passagewaythat extends from the opening in the proximal end to an opening in adistal end. The instrument may be movable through this passageway. Thedistal end is configured for releasable attachment with an artificialairway structure that is attached to the patient. A valve may be locatedin the instrument introduction section and may have a closed position inwhich the passageway is at least substantially isolated from theartificial airway of the patient. The valve may at least substantiallyblock the passageway of the instrument introduction section. The valvemay have an open position that allows for the instrument to be movedthrough the instrument introduction section and into the artificialairway of the patient.

[0013] The present invention also provides for an exemplary embodimentof a respiratory apparatus that includes an artificial airway structurethat is attached to an artificial airway of a patient. An instrumentintroduction section may be present and may be adapted to allow for theintroduction of an instrument into the artificial airway. The instrumentintroduction section may have a proximal end with an opening, and adistal end that is configured for releasable attachment with theartificial airway structure. A passageway is present in the instrumentintroduction section from the opening in the proximal end to an openingin the distal end. A valve may be located in the instrument introductionsection and may at least substantially block the passageway when in aclosed position. The valve may have an open position that allows theinstrument to be moved through the instrument introduction section. Acleaning section may also be provided in the instrument introductionsection, and may be proximal from the valve when the valve is in theclosed position. An irrigation port may be in communication with thecleaning section. The irrigation port may be configured for allowingfluid to be transferred therethrough into the cleaning section. A plugmay be present and may be engageable with the proximal end of theinstrument introduction section. The plug may be adapted to isolate thepassageway from the environment by closing the opening in the proximalend.

[0014] The present invention also provides for a respiratory apparatusthat has an instrument introduction section adapted for introducing aninstrument into an artificial airway of a patient. The instrumentintroduction section may have a proximal end with an opening, and beconfigured for insertion of the instrument into the instrumentintroduction section. A distal end is present on the instrumentintroduction section and may be configured for releasable attachmentwith an artificial airway structure that is attached to the patient. Thedistal end may be releasably attached by a friction fit arrangement. Apassageway is present from the opening in the proximal end to an openingin the distal end. The instrument may be movable through the passageway.A single flap valve may be located in the instrument introductionsection and may have a closed position in which the passageway is atleast substantially blocked from the artificial airway of the patient.The valve may have an open position that allows the instrument to bemoved through the instrument introduction section and into theartificial airway of the patient. A cleaning section may be provided inthe instrument introduction section and may be proximal from the valvewhen the valve is in the closed position. An irrigation port may be incommunication with the cleaning section. The irrigation port may beconfigured for allowing fluid to be transferred into the cleaningsection. A wiper seal may be located in the instrument introductionsection and may be proximal from the cleaning section. A cap may beconfigured to engage the proximal end of the instrument introductionsection. The cap may have an opening that allows for insertion of theinstrument into the opening in the proximal end of the instrumentintroduction section. A plug may be connected to the cap by a tether.The plug may be insertable into the opening in the cap in order to closethis opening.

[0015] The present invention also provides for an exemplary embodimentof a respiratory apparatus as described above which further has a wiperseal that is located in the instrument introduction section proximalfrom the valve.

[0016] Another exemplary embodiment exists in a respiratory apparatus asdescribed above where the valve is a single flap. Still further, inother exemplary embodiments of the present invention the single flap mayhave an aperture therethrough. The single flap may be adapted to beopened by insertion of the instrument through the instrumentintroduction section.

[0017] The instrument introduction section may be releasably attached tothe artificial airway structure through a variety of mechanisms invarious exemplary embodiments of the present invention. For instance, afriction fit arrangement, a threaded engagement, a barb structure, or aclamping ring may be used to releasably attach the instrumentintroduction section to and from the artificial airway structure.

BRIEF DESCRIPTION OF THE DRAWINGS

[0018]FIG. 1 is a perspective view of a respiratory apparatus inaccordance with the present invention. A patient is shown having anartificial airway and an artificial airway structure attached thereto.

[0019]FIG. 2 is a cross sectional elevational view of a respiratoryapparatus in accordance with the present invention. The respiratoryapparatus is shown located proximate to an artificial airway structure.

[0020]FIG. 3 is a cross sectional elevational view of a respiratoryapparatus similar to that shown in FIG. 2. Here, the respiratoryapparatus is attached to the artificial airway structure.

[0021]FIG. 4 is a cross sectional elevational view of a respiratoryapparatus in accordance with the present invention. Here, therespiratory apparatus is located proximate to an artificial airwaystructure that has swiveling ports.

[0022]FIG. 5 is a cross sectional elevational view of a respiratoryapparatus similar to that shown in FIG. 4. Here, the respiratoryapparatus is attached to the artificial airway structure through afriction fit arrangement.

[0023]FIG. 6 is a cross sectional elevational view of a respiratoryapparatus in accordance with the present invention. The respiratoryapparatus is shown located proximate to an artificial airway structurethat has an artificial airway structure valve located therein.

[0024]FIG. 7 is a cross sectional elevational view of a respiratoryapparatus similar to that shown in FIG. 6. Here, the respiratoryapparatus is connected to the artificial airway structure through athreaded engagement.

[0025]FIG. 8 is a cross sectional elevational view of a respiratoryapparatus in accordance with the present invention. A barb is present onthe respiratory apparatus which is used to connect the respiratoryapparatus to the artificial airway structure.

[0026]FIG. 9 is a cross sectional elevational view of a respiratoryapparatus similar to that shown in FIG. 8. Here, the respiratoryapparatus is shown engaging the artificial airway structure, and atubular portion of a suction catheter is shown as passing through therespiratory apparatus and the artificial airway structure.

[0027]FIG. 10 is a cross sectional elevational view of a respiratoryapparatus in accordance with the present invention. Here, therespiratory apparatus is shown as being proximate to an artificialairway structure that has a clamping ring that is used to attach therespiratory apparatus to the artificial airway structure.

[0028]FIG. 11 is a cross sectional elevational view of a respiratoryapparatus similar to that shown in FIG. 10. Here, the respiratoryapparatus is attached to the artificial airway structure.

[0029]FIG. 12 is a cross sectional elevational view of a respiratoryapparatus in accordance with the present invention. Here, therespiratory apparatus is located proximate to an artificial airwaystructure that is a neonate Y-manifold.

[0030]FIG. 13 is a cross sectional elevational view of a respiratoryapparatus similar to that shown in FIG. 12. Here, the respiratoryapparatus is connected to the artificial airway structure through afiction fit arrangement.

[0031]FIG. 14 is a top plan view of an alternative cap and plug assemblyin accordance with the present invention.

[0032]FIG. 15 is a cross sectional view taken along line A-A in FIG. 14.

[0033]FIG. 16 is a cross sectional view taken along line B-B in FIG. 14.

DETAILED DESCRIPTION

[0034] Reference will now be made in detail to embodiments of theinvention, one or more examples of which are illustrated in thedrawings. Each example is provided by way of explanation of theinvention, and is not meant as a limitation of the invention. Forexample, features illustrated or described as part of one embodiment canbe used with another embodiment to yield still a third embodiment. It isintended that the present invention include these and othermodifications and variations.

[0035] As used herein, proximal refers generally to the directiontowards a medical caregiver. Also, distal refers generally to thedirection towards a patient.

[0036] The present invention provides for a respiratory apparatus 10that may be removed from the ventilation circuit of a patient 18 andreplaced without having to disconnect an artificial airway structure 30from the ventilation circuit.

[0037] Referring to FIG. 1, the present invention may be used inconjunction with a variety of instruments that are placed into anartificial airway 34 of a patient 18. By way of example, the presentinvention is shown as being used in conjunction with a suction catheter12 and related apparatus. A ventilator 76 may be in communication withthe artificial airway 34 through an artificial airway structure 30. Theartificial airway structure 30 is sometimes known in the art as amanifold. The ventilator 76 may provide air to and remove air from thepatient 18 through the artificial airway 34.

[0038] If the artificial airway 34 is left in the patient 18 for anysubstantial amount of time, respiratory secretions may build up in thelungs of the patient 18. As such, these secretions may need to beremoved in order to ensure that adequate lung ventilation of the patient18 is maintained. These secretions may be removed through use of thesuction catheter 12. The suction catheter 12 has a tubular portion 14that may be extended through the artificial airway 34 into the lungs ofthe patient 18. A vacuum source 78 may be in communication with theventilating circuit, and more specifically in communication with thesuction catheter 12. A medical caregiver may actuate a suction valve 74thereby applying a vacuum pressure to the tubular portion 14 of thesuction catheter 12. Upon doing so, respiratory secretions in thepatient 18 and in the artificial airway 34 may be removed.

[0039] Respiratory secretions may sometimes remain on the tubularportion 14 of the suction catheter 12 or transfer onto other portions ofthe ventilator circuit. These respiratory secretions are undesirable inthat they provide a breeding ground for pathogens and other harmfulagents that may harm the patient 18. It is therefore the case that thesuction catheter 12 and/or other components of the ventilation circuitmay be cleaned in order to remove any residual respiratory secretions.However, in order to ensure a lower risk of contamination to the patient18, it may be common practice to remove and replace the suction catheter12 and/or other components in the ventilation circuit after some amountof set time has passed, for instance after 24 or 72 hours of use.

[0040] The suction catheter 12 is shown with a flexible plastic sleeve44. The sleeve 44 is present in order to contain and isolate respiratorysecretions that accumulate on the tubular portion 14 of the suctioncatheter 12 as the tubular portion 14 is withdrawn from the ventilationcircuit. The sleeve 44 may be provided on either end with sealingconnections 45 and 47 that attach the sleeve 44 to the suction catheter12.

[0041] In previous devices, the artificial airway structure 30 wasdetachable from the artificial airway 34 so that a new artificial airwaystructure 30 could be incorporated into the ventilation circuit. Thisbreak in the ventilation circuit interrupted the flow of air to thepatient 18 and increased the chances of ventilator associatedcomplications. In the present invention, the respiratory apparatus 10may be removably attached to the artificial airway structure 30. In thisinstance, upon removing the respiratory apparatus 10, the artificialairway structure 30 may remain in place and allow for communicationbetween the ventilator 76 and the artificial airway 34. As such, air maystill be provided to the patient 18 during removal of the respiratoryapparatus 10. A new respiratory apparatus 10 may be reattached to thesame artificial airway structure 30. The suction catheter 12 may bereleasably attachable to the respiratory apparatus 10, and may or maynot be replaced with a new suction catheter 12 during replacement of therespiratory apparatus 10.

[0042] The respiratory apparatus 10 in accordance with the presentinvention may be used in combination with a variety of artificial airwaystructures 30. For instance, in one exemplary embodiment of the presentinvention as shown in FIG. 10, the respiratory apparatus 10 may be usedwith a T-piece artificial airway structure 30. A port 90 is present andmay be attached to the artificial airway 34 (FIG. 1). The port 90therefore allows for communication between the artificial airwaystructure 30 and the artificial airway 34. Air from the ventilator 76(FIG. 1) may be provided to and from the artificial airway structure 30through a port 92. The port 92 may be attached to a pair of ventilationtubes via a connector (not shown). An additional port 94 on theartificial airway structure 30 may be provided opposite the port 92. Theport 94 is typically covered with a cap 68 which is removed when“blow-by” is desired to wean the patient 18 (FIG. 1) from forcedventilation. An additional port 46 may be configured to engage therespiratory apparatus 10 such that the respiratory apparatus 10 may beremovably attached to the artificial airway structure 30.

[0043] The respiratory apparatus 10 is shown in greater detail in FIG.2. The respiratory apparatus 10 includes an instrument introductionsection 22 to which an instrument such as the suction catheter 12(FIG. 1) may be attached in any suitable manner. The instrumentintroduction section 22 has a passageway 24 extending therethrough. Thetubular portion 14 (FIG. 1) of the suction catheter 12 may be advancedthrough the passageway 24, through an opening 98 in the distal end 28 ofthe instrument introduction section 22 and into the artificial airwaystructure 30, and eventually advanced into the artificial airway 34(FIG. 1). Upon retraction of the tubular portion 14 from the patient 18,respiratory secretions may be present on the surface of the tubularportion 14. A wiper seal 36 may be provided in the instrumentintroduction section 22. The wiper seal 36 may be a resilient memberhaving an aperture therethrough that allows for the tubular portion 14to pass. The wiper seal 36 desirably tightly engages the tubular portion14 as the tubular portion 14 is retracted into the proximal end 26 ofthe instrument introduction section 22. Respiratory secretions presenton the surface of the tubular portion 14 may be removed by contact withthe wiper seal 36.

[0044] The instrument introduction section 22 may also be provided witha cleaning section 38. In one exemplary embodiment, the cleaning section38 may be defined by a cleaning section member 86. Additionally oralternatively, the cleaning section 38 may be defined on one end by avalve 32. Further, the cleaning section 38 may alternatively be definedby any portion of the instrument introduction section 22. The valve 32shown in FIG. 2 is a single flap that is hingedly attached to an annularring 31 housed within instrument introduction section 22. The hinge onthe valve 32 may provide both a bias force and a pivoting location. Useof such a valve 32 is disclosed in U.S. Pat. No. 6,227,200 B1 issued toCrump et al., the entire disclosure of which is incorporated byreference herein in its entirety for all purposes. The valve 32 may atleast substantially block the passageway 24.

[0045] As can be seen in FIG. 9, the tubular portion 14 of the suctioncatheter 12 may have a distal end 16 with a distal opening 82. A lumen20 extends through the tubular portion 14 and allows for respiratorysecretions and other fluids to be transferred through the distal opening82 and into the lumen 20 by the vacuum source 78 (FIG. 1). The tubularportion 14 of the suction catheter 12 may be cleaned by positioning thedistal end 16 of the suction catheter 12 either against the valve 32and/or within the cleaning section 38. Upon so positioning, a vacuum canbe effected upon the lumen 20 and lavage or other cleaning solution maybe injected into the cleaning section 38. Application of the vacuumcauses the valve 32 to be forced against the distal end 16 of thetubular portion 14. However, it is to be understood that injection oflavage or other cleaning solutions and/or application of a vacuum may beperformed in other instances not associated with cleaning of the tubularportion 14.

[0046] Although described as contacting the distal end 16 of the tubularportion 14, in certain exemplary embodiments of the present invention,the valve 32 need not contact the distal end 16 of the tubular portion14 in order to effectively clean the tubular portion 14. For instance,the valve 32 may be urged against the cleaning section member 86 duringcleaning of the tubular portion 14.

[0047] The tubular portion 14 may also be provided with at least oneside opening 84. This arrangement allows for turbulent flow to beestablished within the cleaning section 38 during suctioning causing thelavage solution to break up and remove any respiratory secretionspresent on the tubular portion 14. Respiratory secretions may be removedthrough the side opening 84 and/or the distal opening 82. The valve 32may be provided with an aperture 42 therethrough. The presence of theaperture 42 may help to establish a more desirable turbulent fluid flowwithin the cleaning section 38. In one exemplary embodiment of thepresent invention, the aperture 42 may be about 0.03 inches in diameter.

[0048] An irrigation port 40 may be attached to the instrumentintroduction section 22 in order to allow for the injection of thelavage solution. A container (not shown) holding the lavage solution mayhave an outlet inserted into the irrigation port 40. Lavage may then bedispensed from this container into the irrigation port 40 which may bein communication with the cleaning section 38. The irrigation port 40may also be provided with an irrigation cap 70 that may be connected tothe irrigation port 40 by way of a tether 72. The irrigation cap 70 maybe placed onto the irrigation port 40 in order to close the irrigationport 40 when not in use.

[0049] In certain exemplary embodiments of the present invention, thecleaning section member 86 may be configured such that a small amount ofspace is present between the tubular portion 14 of the suction catheter12 and the cleaning section member 86. In certain exemplary embodimentsof the present invention, this space may be between about 0.005 andabout 0.015 inches. This space provides two advantages. First, if lavageis needed to be provided to the patient 18, injection of lavage throughthe irrigation port 40 and then into the cleaning section 38 causes astream of lavage solution to be directed out of the instrumentintroduction section 22 and into the patient 18. Second, as the tubularportion 14 is withdrawn the close proximity between the tubular portion14 and the cleaning section member 86 may help to wipe any heavy layersof respiratory secretions from the outside of the tubular portion 14 ofthe suction catheter 12.

[0050] Employment of the valve 32 is advantageous in that the tubularportion 14 of the suction catheter 12 may be cleaned without causing apressure loss to the ventilation circuit. This is because the valve 32at least substantially isolates the portion of the respiratory apparatus10 proximal the valve 32 from the remainder of the ventilation circuit.In one exemplary embodiment of the present invention, the valve 32 maybe provided with one or more projections 88. FIG. 9 shows therespiratory apparatus 10 engaged with the artificial airway structure30. In this case, the artificial airway structure 30 is a neonatemanifold. The tubular portion 14 of the suction catheter 12 is shown asbeing advanced through the instrument introduction section 22, theartificial airway structure 30, and out of the port 90 eventuallyenabling entry of the artificial airway 34 (FIG. 1) of the patient 18(FIG. 1). The valve 32 may be opened by insertion of the tubular portion14 through the instrument introduction section 22. The projection 88 maybe configured to minimize valve 32 contact with the surface of thetubular portion 14. This contact helps to reduce contamination ofrespiratory secretions from the tubular portion 14 onto the valve 32 andrelated components due to the minimized contact afforded by theprojections 88. Additionally, in certain exemplary embodiments, thiscontact may help to ensure the structural integrity of the valve 32 andmay minimize any unnecessary bending or stress on the valve 32.

[0051] In one exemplary embodiment of the present invention, the valve32 may be biased towards the closed position. Although shown in FIG. 9as being attached to an annular ring 31, the valve 32 may alternativelybe attached, for example, directly onto a wall of the instrumentintroduction section 22. The valve 32 may be configured to be closedonce the tubular portion 14 is positioned proximally from the valve 32,or alternatively the valve 32 may be configured to be closed upon theproximal positioning of the tubular portion 14 from the valve 32 andapplication of vacuum through the lumen 20 in order to draw the valve 32into a closed position.

[0052] The valve 32 need not be a single flap in other exemplaryembodiments of the present invention nor need it have the annular ring31, nor need it have the aperture 42, or the projection 88. It is to beunderstood that the configuration of the valve 32 shown in the drawingsis only a desired embodiment, and other configurations of the valve 32are possible in accordance with the present invention. For instance, thevalve 32 may be one, two, three, or more flaps that are biased towards aclosed position and opened by insertion of the tubular portion 14 of thesuction catheter 12 or any other suitable instrument through theinstrument introduction section 22.

[0053] Referring back to FIG. 2, the instrument introduction section 22is provided with a proximal end 26 and a distal end 28. The proximal end26 may be releasably attached to the suction catheter 12 through avariety of means commonly known in the art. For instance, these twocomponents may be friction fit to one another, clamped to one another,or connected through a threaded engagement. Other suitable connectionssuch as a snap fit, a latch, a boss and detent, etc. may be used. Thedistal end 28 of the instrument introduction section 22 may beconfigured for being releasably attachable to a port 46 on theartificial airway structure 30. Engagement of the distal end 28 of theinstrument introduction section 22 and the port 46 is shown in FIG. 3.In this exemplary embodiment, the distal end 28 may be friction fit ontothe port 46. This provides for a secure attachment between therespiratory apparatus 10 and the artificial airway structure 30, butalso allows for the disengagement of these two components once thedesire to replace the respiratory apparatus 10 is present. Theartificial airway structure 30 shown in FIG. 3 may be provided with anadditional port 80 onto which the respiratory apparatus 10 may beattached in other exemplary embodiments. Additionally, in yet otherexemplary embodiments of the present invention, two respiratoryapparatuses 10 may be employed such that their respective distal ends 28are engageable with the port 46 and the port 80.

[0054] The respiratory apparatus 10 is shown in FIG. 5 as being providedwith a cap 100 placed on the proximal end 26 of the instrumentintroduction section 22. An opening 102 in the cap 100 may be providedthrough which the suction catheter 12 may be passed prior to beingpassed through an opening 96 in the proximal end 26 of the instrumentintroduction section 22. The opening 102 may be sized so that variousinstruments may be used in conjunction with the respiratory apparatus10. The opening 102 may be closed by a plug 104 that is desirablyconnected to the cap 100 by way of a tether 106. FIG. 5 shows anexemplary embodiment where the plug 104 is inserted into the opening 102(FIG. 4), hence acting to close the opening 96 in the proximal end 26 ofthe instrument introduction section 22. Closing off the opening 96 mayhelp to prevent contamination of the respiratory apparatus 10 bycontaminants in the environment when instruments are not being used inconjunction with the respiratory apparatus 10. Additionally, duringmechanical ventilation of the patient 18, it is advantageous to closethe opening 96 so that positive end expiratory pressure can bemaintained in the ventilation circuit. Although it is also possible tomaintain the positive end expiratory pressure through the use of thevalve 32 or a PEEP seal (not shown), the use of the plug 104 to closeoff the proximal end 26 provides for an alternative or supplemental wayof maintaining the positive end expiratory pressure. As suggested above,the cap 100 need not be provided on the respiratory apparatus 10. Forinstance, FIG. 9 illustrates an exemplary embodiment that does not havesuch a cap 100 present.

[0055]FIGS. 14-16 show an alternative arrangement of the cap 100 and theplug 104 in accordance with an exemplary embodiment of the presentinvention. Here, an attachment member 114 is present and may be attachedto any component of the respiratory apparatus 10, for example theproximal end 26. The cap 100 is shown as being connected to theattachment member 114 by way of the tether 106, while the plug 104 isconnected to the attachment member 114 by a separate plug tether 116.The cap 100 may be placed over a portion of the respiratory apparatus10, for instance the opening 96. Further, when desired, the plug 104 maybe placed within the opening 102 in the cap 100.

[0056]FIG. 4 shows an alternate exemplary embodiment of the presentinvention where the cap 100 with the attachment member 114 may beattached to the port 46 of the artificial airway structure 30. The plug104 may be inserted into the cap 100 in order to close off the port 46.FIG. 5 shows the cap 100 and plug 104 removed in order to allowattachment of the respiratory apparatus 10 to the artificial airwaystructure 30. In other exemplary embodiments of the present invention,however, the distal end 28 of the respiratory apparatus 10 may beinserted into the port 46 of the artificial airway structure 30 withoutremoving the cap 100 from the port 46.

[0057] As shown in FIG. 3, the port 46 is in axial alignment with aswiveling port 62 that may be further attached to the artificial airway34 (FIG. 1). A rotating member 60 may be provided on the artificialairway structure 30 that allows for the rotation of the ports 46 and 80such that port 80 may be axially aligned with the swiveling port 62,hence moving port 46 out of axial alignment with port 62. This type ofartificial airway structure 30 is disclosed in U.S. Pat. No. 5,735,271to Lorenzen et al., the entire disclosure of which is incorporated byreference herein in its entirety for all purposes. The artificial airwaystructure 30 has another swiveling port 64 located thereon that is incommunication with the ventilator 76. These two swiveling ports 62 and64 are provided with a swiveling feature so that the tubing and/orstructure connected to them more easily moves when various parts of theventilation circuit are manipulated or moved. This helps to reducestress imparted onto the patient 18 (FIG. 1) brought about by movementof the ventilation circuit. The swiveling ports 62 and 64 may beconstructed, for instance, as those disclosed in U.S. Pat. No. 5,694,922to Palmer, the entire disclosure of which is incorporated by referenceherein in its entirety for all purposes.

[0058] Another exemplary embodiment of the present invention is shown inFIG. 4. Here, the respiratory apparatus 10 may be substantially similarto the respiratory apparatus 10 described above with respect to theexemplary embodiment shown in FIG. 2. However, the artificial airwaystructure 30 to which the respiratory apparatus 10 may be removablyattached is in this instance an elbow manifold that has a pair ofswiveling ports 62 and 64. FIG. 5 shows the respiratory apparatus 10attached to the artificial airway structure 30 in much the same way asdiscussed above in respect to the exemplary embodiment shown in FIG. 3,that being a friction fit arrangement between the port 46 and the distalend 28 of the instrument introduction section 22. It is to be understoodthat the present invention is not limited to a particular amount offriction between the port 46 and the distal end 28 of the instrumentintroduction section 22. For instance these two parts may be tightly fitwith respect to one another such that a medical caregiver must provide alarge amount of force in order to remove the distal end 28 of theinstrument introduction section 22 from the port 46. Conversely, thesetwo parts may be fit together such that only a small amount of force isneeded to remove the distal end 28 of the instrument introductionsection 22 from the port 46. The present invention is to be understoodas encompassing exemplary embodiments of the respiratory apparatus 10that may be fit onto the artificial airway structure 30 with varyingdegrees of friction between these two components.

[0059] Although shown as being inserted (in FIGS. 3, 5, 7, 9, 11, and13) within the port 46, the distal end 28 of the instrument introductionsection 22 may in other exemplary embodiments be sized to fit around theport 46. Additionally, other friction fit arrangements between the port46 and the distal end 28 are possible in accordance with the presentinvention as is commonly known in the art.

[0060] Yet another exemplary embodiment of the present invention isdisclosed in FIG. 6. Here, the artificial airway structure 30 may be anelbow manifold that has ports 90 and 92 located thereon that do notinclude the swiveling feature. These two ports 90 and 92 form part ofthe ventilation circuit that provides air to and from the patient 18(FIG. 1) through the port 90 and provides air to and from the ventilator76 (FIG. 1 ) through the port 92. As stated, the respiratory apparatus10 may be disengaged from the artificial airway structure 30 without theneed to remove the artificial airway structure 30 from the remainder ofthe ventilation circuit. This helps to ensure that air is still providedto the patient 18 (FIG. 1) during replacement of the respiratoryapparatus 10. However, it may be the case that a small amount of air islost due to the opening in the port 46 once the respiratory apparatus 10is disengaged therefrom. In order to further minimize the loss ofpositive end expiratory pressure, the artificial airway structure 30 maybe provided with an artificial airway structure valve 66.

[0061] The artificial airway structure valve 66 may prevent air lossduring removal of the respiratory apparatus 10 by sealing off the port46. The artificial airway structure valve 66 may take any designcommonly known in the art. For instance, as disclosed in FIG. 6, theartificial airway structure valve 66 may be a single flap that issubstantially similar to the valve 32, of the instrument introductionsection 22. The artificial airway structure valve 66 may be biasedtowards a closed position, and may be opened upon the insertion of thetubular portion 14 (FIG. 1) through the port 46 and into the port 90.Although shown as being a single flap, the artificial airway structurevalve 66 may also be a plurality of flaps. Additionally, the artificialairway structure valve 66 may be a mechanism that does not have flapsbut yet still provides for a closed port 46 during disengagement of therespiratory apparatus 10 from the artificial airway structure 30.

[0062] Additionally, the valve 32 and the artificial airway structurevalve 66 may be of the other configurations in other exemplaryembodiments of the present invention. For instance, configurationsdisclosed in commonly owned U.S. Pat. No. 6,227,200 B1 issued to Crumpet al., may be employed which may be a twisting membrane, a duckbillarrangement, or a dual membrane configuration having offset apertures.

[0063] The artificial airway structure valve 66 may be configured suchthat it is closed during disengagement of the respiratory apparatus 10,but opened upon insertion of the distal end 28 of the instrumentintroduction section 22 into the port 46. Additionally, the artificialairway structure valve 66 may be configured to be opened by insertion ofthe tubular portion 14 (FIG. 1) through the port 46 and into theartificial airway structure 30. In this instance, it may be the casethat the artificial airway structure valve 66 is also in need ofcleaning due to contact with respiratory secretions from the tubularportion 14. In this instance, the distal end 16 (FIG. 1) of the tubularportion 14 may be located proximate to the artificial airway structurevalve 66 and lavage solution may be injected into this location throughthe irrigation port 40. Vacuum may be applied to the lumen 20 of thetubular portion 14 and respiratory secretions present may then beremoved via a process substantially the same as the cleaning procedurewith respect to the valve 32.

[0064] Additionally, other ways of releasably attaching the respiratoryapparatus 10 to the artificial airway structure 30 are possible inaccordance with the present invention. FIGS. 6 and 7 show a threadedengagement where the distal end 28 of the instrument introductionsection 22 may have external threading 48 located thereon. The port 46may have internal threading 50 located therein and is configured to matewith the external threading 48. FIG. 7 shows the threaded engagementbetween the respiratory apparatus 10 and the artificial airway structure30. In order to effect this attachment, the medical caregiver needs torotate the respiratory apparatus 10 and the artificial airway structure30 with respect to one another.

[0065] Another configuration for releasably attaching the respiratoryapparatus 10 to the artificial airway structure 30 is disclosed in FIG.8. Here, the artificial airway structure 30 is a neonate manifold havinga plurality of ports. Three such ports are labeled 46, 90, and 92. Theport 92 may provide access to and from the ventilator 76 (FIG. 1), andthe port 90 may provide access to and from the artificial airway 34(FIG. 1) of the patient. The port 46 may be configured to be releasablyengageable with the distal end 28 of the respiratory suction catheterapparatus 10. The distal end 28 may be provided with a barb 52 thatextends from the distal end 28. The barb 52 and the distal end 28 may beforce fit into the port 46 and slid distally. The port 46 may beprovided on one end with a receiving area 54 that is designed so as toreceive the barb 52. As the barb 52 is moved into the receiving area 54,the distal end 28 of the instrument introduction section 22 is retainedin the port 46. This engagement is shown in FIG. 9. In order to removethe respiratory apparatus 10 from the artificial airway structure 30,the medical caregiver may provide a force tending to separate these twocomponents. This force will be enough to compress the barb 52 and/ordeform the distal end 28 such that they may be slid out of the port 46and effect disengagement of the respiratory apparatus 10.

[0066] Yet another exemplary embodiment of the present invention isshown in FIG. 10. Here, the artificial airway structure 30 may be aT-piece manifold, having the port 46 located thereon in order to bereleasably attached to the distal end 28 of the respiratory suctioncatheter apparatus 10. A clamping ring 56 may be provided and surroundsthe exterior of the port 46. The clamping ring 56 may be a single pieceof material, for instance metal or medical grade plastic, that exhibitsat least a slight amount of flexibility. The clamping ring 56 has holes(not shown) on either end through which a screw 58 may be positioned.The distal end 28 of the instrument introduction section 22 may beinserted into the port 46 as shown in FIG. 11, and the screw 58 may beturned such that the two ends of the clamping ring 56 are urged towardsone another. This in turn causes the port 46 to be compressed such thatit is forced against the distal end 28 of the instrument introductionsection 22 causing a secure attachment between the respiratory apparatus10 and the artificial airway structure 30. Additionally, a nut (notshown) may engage the screw 58 and may also be used to effect theconstriction of the clamping ring 56 as is commonly known in the art.The screw 58 may be loosened in order to separate the two ends of theclamping ring 56 from one another. This loosens the connection betweenthe distal end 28 and the port 46 and allows for the respiratoryapparatus 10 to be removed from the artificial airway structure 30.

[0067] An additional exemplary embodiment of the present invention isshown in FIG. 12. Here, the respiratory apparatus 10 is configuredsubstantially the same as the respiratory apparatus 10 of FIG. 2.However, the artificial airway structure 30 onto which it is releasablyattached is shown as a neonate Y-manifold. FIG. 13 shows the distal end28 of the respiratory apparatus 10 being connected to the port 46 on theartificial airway structure 30 through a friction fit arrangement aspreviously described. Ports 90 and 92 of the artificial airway structure30 allow for communication between the ventilator 76 and the artificialairway 34. A tapered adaptor 112 may be retained within the port 90 inorder to allow for connection of the respirator apparatus 10 to tubingor other components of the respiratory circuit. The tapered adaptor 112may or may not be permanently attached to the port 90. Alternatively,the artificial airway structure 30 itself may be tapered, henceeliminating the need for the tapered adaptor 112 in other exemplaryembodiments of the present invention.

[0068] In accordance with the present invention, the respiratoryapparatus 10 may be sized such that it may be attached to a variety ofartificial airway structures 30. As such, the present invention includesvarious sizes of the respiratory apparatus 10 along with various sizesand configurations of the artificial airway structure 30. The examplesof which described herein are only exemplary embodiments of the presentinvention and do not limit the present invention. Additionally, variousways of releasably attaching the distal end 28 of the introductionsection 22 to the artificial airway structure 30 are possible inaccordance with the present invention, the mechanisms disclosed hereinbeing only exemplary embodiments.

[0069] Although embodiments of the present invention have been describedas being used in connection with a suction catheter 12 as shown in FIG.1, it is to be understood that the instrument may be something otherthan a suction catheter 12 in accordance with other exemplaryembodiments of the present invention. For instance, FIG. 11 shows therespiratory apparatus 10 having a bronchoscope 108 insertedtherethrough. The bronchoscope 108 may be inserted through thepassageway 24, into the artificial airway structure 30, and into theartificial airway 34 of the patient 18 (FIG. 1). Also, the bronchoscope108 may be cleaned in much the same way as describe above with respectto the suction catheter 12. For instance, the tip of the bronchoscope108 may be positioned proximate to the valve 32, lavage solution may beinjected into the cleaning section 38, and suction may be appliedthrough the bronchoscope 108 so that respiratory sections are removedfrom the surface of the bronchoscope 108. Alternatively, other suitableinstruments, such as an endoscope, may be used in conjunction with therespiratory apparatus 10. The respiratory apparatus 10 therefore allowsfor different instruments to be placed therethrough and to be able to becleaned by insertion of lavage solution and/or application of suction tothe instrument. The respiratory apparatus 10 allows for different typesof instruments to be inserted into the artificial airway 34 withouthaving to disconnect the artificial airway structure 30 and cause theaforementioned interruption in ventilation air to the patient.Additionally, the valve 32 may act to maintain positive end expiratorypressure when in the closed position. It is to be understood that thepresent invention is not limited to a respiratory apparatus 10 that isused in conjunction with a suction catheter 12, but may be used with anysuitable instrument that is to be inserted into the artificial airway34. Therefore, different types of instruments may be interchanged withthe respiratory apparatus 10.

[0070] It should be understood that the present invention includesvarious modifications that can be made to the embodiments of therespiratory apparatus described herein as come within the scope of theappended claims and their equivalents.

What is claimed is:
 1. A respiratory apparatus, comprising: aninstrument introduction section adapted for introducing an instrumentinto an artificial airway of a patient, the instrument introductionsection comprising: a proximal end with an opening, the proximal endconfigured for insertion of the instrument into the instrumentintroduction section; a distal end configured for releasable attachmentwith an artificial airway structure attached to the patient; and apassageway from the opening in the proximal end to an opening in thedistal end such that the instrument is moveable through the passageway;and a valve located in the instrument introduction section, the valvehaving a closed position in which the passageway is at leastsubstantially blocked from the artificial airway of the patient, thevalve having an open position allowing the instrument to be movedthrough the instrument introduction section and into the artificialairway of the patient.
 2. The respiratory apparatus of claim 1, furthercomprising: a cap configured to engage the proximal end of theinstrument introduction section, the cap having an opening allowing forinsertion of the instrument into the opening in the proximal end of theinstrument introduction section.
 3. The respiratory apparatus of claim1, further comprising a plug configured to engage the proximal end ofthe instrument introduction section to close the opening in the proximalend of the instrument introduction section.
 4. The respiratory apparatusof claim 1, wherein the instrument is selected from the group consistingof a suction catheter, an endoscope, and a bronchoscope.
 5. Therespiratory apparatus of claim 1, wherein the instrument is a suctioncatheter, the proximal end of the instrument introduction sectionconfigured for releasable attachment with the suction catheter, thesuction catheter having a tubular portion advanceable through thepassageway of the instrument introduction section.
 6. The respiratoryapparatus of claim 1, further comprising a wiper seal located in theinstrument introduction section proximal from the valve.
 7. Therespiratory apparatus of claim 1, further comprising: a cleaning sectionlocated in the instrument introduction section proximal from the valve;and an irrigation port in communication with the cleaning section, theirrigation port configured for allowing fluid to be transferredtherethrough into the cleaning section.
 8. The respiratory apparatus ofclaim 1, wherein the valve is a single flap.
 9. The respiratoryapparatus of claim 8, wherein the single flap has an aperturetherethrough, the single flap is adapted to be opened by insertion ofthe instrument through the instrument introduction section.
 10. Therespiratory apparatus of claim 1, wherein the valve is biased towardsthe closed position.
 11. The respiratory apparatus of claim 1, whereinthe distal end of the instrument introduction section is releasablyattachable to the artificial airway structure by a friction fitarrangement.
 12. The respiratory apparatus of claim 1, wherein thedistal end of the instrument introduction section has threading thereonfor being releasably attachable to the artificial airway structure by athreaded engagement.
 13. The respiratory apparatus of claim 1, whereinthe distal end of the instrument introduction section has at least onebarb located thereon for being releasably attachable to the artificialairway structure.
 14. The respiratory apparatus of claim 1, furthercomprising a clamping ring engageable with the distal end of theinstrument introduction section and adapted to releasably attach theinstrument introduction section to the artificial airway structure. 15.The respiratory apparatus of claim 1, wherein the artificial airwaystructure is selected from the group consisting of a rotatable manifold,an elbow manifold, a T-manifold, and a Y-manifold.
 16. The respiratoryapparatus of claim 1, wherein the artificial airway structure has avalve located therein for preventing air loss.
 17. The respiratoryapparatus of claim 1, further comprising; a cap configured to engage theproximal end of the instrument introduction section, the cap having anopening that allows for insertion of the instrument into the opening inthe proximal end of the instrument introduction section; and a plughaving a plug tether, the plug insertable into the opening in the cap toclose the opening in the cap.
 18. The respiratory apparatus of claim 1,further comprising: a cap configured to engage a port of the artificialairway structure, the cap having an opening that allows for insertion ofthe instrument into the artificial airway structure; and a plug having aplug tether, the plug insertable into the opening in the cap to closethe opening in the cap.
 19. The respiratory apparatus of claim 1,further comprising a positive end expiratory pressure cap adapted toclose the proximal end of the instrument introduction section.
 20. Arespiratory apparatus, comprising: an artificial airway structureattached to an artificial airway of a patient; an instrumentintroduction section adapted for introducing an instrument into theartificial airway of the patient, the instrument introduction sectioncomprising: a proximal end with an opening; a distal end configured forreleasable attachment with the artificial airway structure; and apassageway from the opening in the proximal end to an opening in thedistal end; a valve located in the instrument introduction section andat least substantially blocking the passageway when in a closedposition, the valve having an open position allowing the instrument tobe moved through the instrument introduction section; a cleaning sectionprovided in the instrument introduction section proximal from the valvewhen the valve is in the closed position; an irrigation port incommunication with the cleaning section, the irrigation port configuredfor allowing fluid to be transferred therethrough into the cleaningsection; and a plug engageable with the proximal end of the instrumentintroduction section, the plug adapted to isolate the passageway fromthe environment by closing the opening in the proximal end.
 21. Therespiratory apparatus of claim 20, further comprising a wiper seallocated in the instrument introduction section proximal from the valve.22. The respiratory apparatus of claim 20, wherein the valve is a singleflap.
 23. The respiratory apparatus of claim 22, wherein the single flaphas an aperture therethrough, the single flap is adapted to be opened byinsertion of the instrument through the instrument introduction section.24. The respiratory apparatus of claim 20, wherein the valve is biasedtowards the closed position.
 25. The respiratory apparatus of claim 20,wherein the distal end of the instrument introduction section isreleasably attachable to the artificial airway structure by a frictionfit arrangement.
 26. The respiratory apparatus of claim 20, wherein thedistal end of the instrument introduction section has threading thereonfor being releasably attachable to said artificial airway structure by athreaded engagement.
 27. The respiratory apparatus of claim 20, whereinthe distal end of the instrument introduction section has at least onebarb located thereon for being releasably attachable to the artificialairway structure.
 28. The respiratory apparatus of claim 20, furthercomprising a clamping ring engageable with the distal end of theinstrument introduction section and adapted to releasably attach theinstrument introduction section to the artificial airway structure. 29.The respiratory apparatus of claim 20, wherein the artificial airwaystructure is selected from the group consisting of a rotatable manifold,an elbow manifold, a T-manifold, and a Y-manifold.
 30. The respiratoryapparatus of claim 20, further comprising a cap configured to engage theproximal end of the instrument introduction section, the cap having anopening allowing for insertion of the instrument into the opening in theproximal end of the instrument introduction section.
 31. The respiratoryapparatus of claim 20, wherein the instrument is selected from the groupconsisting of a suction catheter, an endoscope, and a bronchoscope. 32.The respiratory apparatus of claim 20, wherein the instrument is asuction catheter, the proximal end of the instrument introductionsection configured for releasable attachment with the suction catheter,the suction catheter having a tubular portion advanceable through thepassageway of the instrument introduction section.
 33. The respiratoryapparatus of claim 20, wherein the artificial airway structure has avalve located therein for preventing air loss.
 34. The respiratoryapparatus of claim 20, further comprising: a cap configured to engagethe proximal end of the instrument introduction section, the cap havingan opening that allows for insertion of the instrument into the openingin the proximal end of the instrument introduction section; and a plugtether connected to the plug, and wherein the plug is insertable intothe opening in the cap to close the opening in the cap while at the sametime adapted to isolate the passageway of the instrument introductionsection from the environment by closing the opening in the proximal endand the opening in the cap.
 35. A respiratory apparatus, comprising: aninstrument introduction section adapted for introducing an instrumentinto an artificial airway of a patient, the instrument introductionsection comprising: a proximal end with an opening configured forinsertion of the instrument into the instrument introduction section; adistal end configured for releasable attachment with an artificialairway structure attached to the patient, the distal end beingreleasably attached by a friction fit arrangement; and a passageway fromthe opening in the proximal end to an opening in the distal end suchthat the instrument is movable through the passageway; a single flapvalve located in the instrument introduction section, the single flapvalve having a closed position in which the passageway is at leastsubstantially blocked from the artificial airway of the patient, thevalve having an open position allowing the instrument to be movedthrough the instrument introduction section and into the artificialairway of the patient; a cleaning section provided in the instrumentintroduction section proximal from the valve when the valve is in theclosed position; an irrigation port in communication with the cleaningsection, the irrigation port configured for allowing fluid to betransferred therethrough into the cleaning section; a wiper seal locatedin the instrument introduction section and proximal from the cleaningsection; a cap configured to engage the proximal end of the instrumentintroduction section, the cap having an opening allowing for insertionof the instrument into the opening in the proximal end of the instrumentintroduction section; and a plug connected to the cap by a tether, theplug insertable into the opening in the cap to close the opening in saidcap.